District Court Enters Permanent Injunction to Prevent Dallas Compounding Pharmacy and Three Individuals from Distributing Adulterated Drugs
The U.S. District Court for the Northern District of Texas entered a consent decree for permanent injunction against Downing Labs LLC, Ashley Michelle Downing, Christopher Van Downing and Roger E. Mansfield to prevent them from distributing adulterated drugs in interstate commerce, the Department of Justice announced today.
The department filed a complaint in the U.S. District Court for the Northern District of Texas on Jan. 4, 2016, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Downing Labs manufactures, packs, labels and distributes drugs in interstate commerce. As noted in the complaint, Downing Labs has been engaged in manufacturing drugs that, by virtue of their labeling and/or route of administration, purport to be or are intended to be sterile. The complaint alleges that Downing Labs has a long history of manufacturing drug products under conditions that fall short of the minimum requirements to ensure safety and quality.
“The permanent injunction requires Downing Labs and the individual defendants to bring their processes into compliance with the law, which is essential to ensuring that Downing Labs’ drug products are safe for the American public,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will remain vigilant in protecting consumers from pharmaceutical drugs that do not meet the safety protections provided under federal law.”
The federal Food, Drug, and Cosmetic Act defines adulterated drugs as those that are prepared or held under conditions where the drugs may become contaminated with filth or may become injurious to health. The Act also defines drugs as adulterated if the facilities or controls used for the drugs’ manufacture are not in conformity with current good manufacturing practices (CGMP).
The complaint alleges, among other things, that Downing Labs, its owners - Ashley and Christopher Downing - and pharmacist-in-charge, Roger E. Mansfield, violate the Act by introducing or delivering for introduction into interstate commerce sterile drugs that are adulterated in that they are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth and/or rendered injurious to health. The complaint also alleges that defendants violate the Act by introducing or delivering for introduction into interstate commerce drugs that are adulterated in that the methods used in, or the facilities or controls used for, their preparation do not comply with CGMP requirements.
According to the complaint, the FDA conducted multiple inspections of Downing Labs and its predecessor, NuVision Pharmacy Inc. (NuVision), during the past three years. These inspections revealed numerous deficiencies, many of which had to do with the firm’s sterile drug production. The complaint alleges, for example, that test records obtained from the company pursuant to a September to October 2015 inspection showed excessively high levels of endotoxins in recently manufactured drug products. These products were not distributed. Endotoxins are substances found in certain bacteria that can cause a wide variety of serious reactions in humans, including high fever and shock.
FDA identified additional sterility problems during inspections in 2013 and 2014, according to the complaint. In 2014, Downing Labs’ records showed that 19 lots of supposedly sterile drugs had tested positive for various microorganisms, including the pathogens Staphylococcus haemolyticus, which can cause septicemia, peritonitis and urinary tract infections and Nocardia nova, which can cause pneumonia, sinusitis and skin infections. These products were not distributed. According to the complaint, however, FDA found that the company had failed to adequately investigate the cause of the sterility problems in the 19 lots.
According to the complaint, Downing Labs was formed in December 2013, purchased NuVision in January 2014 and obtained its pharmacy license from the state of Texas in June 2014. Defendant Ashley Michelle Downing serves as Downing Labs’ director and vice-president. She is responsible for all operations of the company. She previously held several positions at NuVision, including director, production manager, and quality manager. Defendant Christopher Van Downing, husband of Ashley Michelle Downing, is Downing Labs’ president, with responsibilities that include overall business management and compliance. Defendant Roger E. Mansfield became the pharmacist-in-charge at Downing Labs on Dec. 30, 2014, and is responsible for all pharmacy operations, including sterile drug production and oversight. He was a staff pharmacist at Downing Labs prior to becoming the pharmacist-in-charge.
The permanent injunction entered by U.S. District Judge Sam A. Lindsay for the Northern District of Texas enjoins the defendants from manufacturing, holding, or distributing drugs manufactured at or from their McEwen Road facility (located at 4001McEwen Road, Suite 110, Dallas, Texas) unless the defendants comply with the Act and associated drug manufacturing regulations. Under the injunction, Downing Labs will need to stop manufacturing, holding or distributing human drugs from its McEwen Road facility until it complies with the Act and regulations and the Decree. In addition, the permanent injunction authorizes the FDA to order Downing Labs to stop drug manufacturing should FDA determine that Downing Labs has violated the terms of the decree. The decree also authorizes the FDA to order Downing Labs to recall drugs that have been distributed by the firm or to destroy drugs that are in the process of being manufactured. Certain provisions of the injunction do not apply to drugs that defendants manufacture, hold, and/or distribute for animal use.
The government is represented by Trial Attorneys David A. Frank and Raquel Toledo of the Civil Division’s Consumer Protection Branch, with assistance of Associate Chief Counsel Michael D. Shane of the Department of Health and Human Services’ Office of General Counsel-Food and Drug Division and Assistant U.S. Attorney Mary M. (Marti) Cherry of the Northern District of Texas.